Maha FDA to prosecute Mumbai based firm for stocking drugs without license
Mumbai, October, 2016:
Against the backdrop of illegal stock and sale of medicines, the Maharashtra Food and Drug Administration (FDA) is planning to prosecute a Mumbai-based firm which was procuring and stocking drugs without a license in contravention to the provisions of Drugs & Cosmetic Act, 1940.
Maharashtra FDA is planning to prosecute the firm on the basis of stocking drugs, procuring drugs without a license and proper purchase documents under Section 18(c), 18(a)(vi) read with Rule 65(5) of D&C Act and rules thereunder.
Based on the investigation that the firm procured purchase invoices from three firms illegally, stocks of drug worth Rs. 18 lakhs were also seized from the godown at Bhiwandi in Thane district.
Violations of D&C Act have been rampant since the past six months relating to not having proper purchase and sale bill and absence of pharmacists in the drug retail stores across the city. Cases detected during surprise raids amounting to violation under D&C Act included even dispensing Schedule H drugs without prescription by unqualified people to the patients.
Stop sale notices were earlier issued while the state regulator made surprise checks at 11 such drug retail stores and found that pharmacists were absent in two of the stores of Mumbai region in violation of Rule 65(2) of the D&C Act which attracts penalty both under Pharmacy Act and Drugs and Cosmetics Act for professional misconduct.
Licenses of 500 retail pharmacies were cancelled and of another 1,674 retail drug stores were suspended as a part of inspections done on 18,067 retail pharmacies across the state between April 2015 and January 2016.
The state regulator had in the past cancelled eight licenses and suspended another 30 during the period between May 1, 2016 and May 23, 2016 for non-compliance to D&C Act. Out of the eight cancelled, six were retail licenses and two were wholesale licenses. Out of 30 suspended, 23 were retail licenses and 7 were wholesale licenses.
The state drug regulator in the past had also served 2,428 show cause notices on the retailers based on violations of D&C Act like dispensing medicines without prescription, without proper bill and for absence of pharmacists. Pharmabiz